BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLENITY

    MDR report key: 16690495 · Received April 5, 2023

    Report

    Report Number
    MW5116393
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    March 22, 2023
    Report Date
    April 3, 2023
    Manufacturer
    RO / GELESIS INC.
    Product Code
    QFQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADVISE FROM MY DOCTOR ABOUT TAKING PLENITY (COMPANY CALLS RO) PILLS FOR WEIGHT LOSS, I WENT THROUGH THE INTERVIEW PROCESS TO GET THEM, AND I'M SORRY I DID, I ENDED UP IN THE HOSPITAL FOR 3 DAYS WITH TUBES STICKING OUT OF NOSE INTO MY STOMACH TO GET MY SMALL INTESTINE TO UNBLOCK. SEVERE ABDOMINAL PAIN LIKE I WAS BEING CRUSHED. THIS MEDICATION OR SUPPLEMENT IS VERY DANGEROUS AND THEY SHOULD BE STOPPED FROM PRESCRIBING AND PROFITING FROM IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519710 PLENITY INGESTED, TRANSIENT, SPACE OCCUPYING DEVICE FOR WEIGHT MANAGEMENT AND/OR WEIGHT QFQ RO / GELESIS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Life Threatening| R| H ATORVASTATIN | LISINOPRIL| PANTOPRAZOLE